Rotator Cuff SyndromeBITENCT02655848

Tenotomy or Tenodesis of Long Head Biceps in Arthroscopic Rotator Cuff Repair

A study testing Arthroscopic rotator cuff repair, LHB Tenodesis and LHB Tenotomy in people with Rotator Cuff Syndrome, run by Onze Lieve Vrouwe Gasthuis at 10 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for: Rotator Cuff Syndrome
What is being tested?: Arthroscopic rotator cuff repair, LHB Tenodesis and LHB Tenotomy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 98 participants
Where: 10 sitesNetherlands
Study dates: Jul 2012to Sep 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients older than 50 years
Degenerative rotator cuff lesion of supraspinatus/infraspinatus tendon, smaller than three centimeter.
Patients need to be able to read and write in Dutch or English language in order to complete the questionnaires, and sign informed consent.

Who cannot join

Acute, traumatic or partial thickness rotator cuff rupture, or in case a full thickness tear is larger than 3 cm measured using an arthroscopic ruler.
Accompanying subscapularis tendon lesion
Hour-glass deformation bicepstendon origin or in case of accompanying subscapularis tendon rupture.
Osteoarthritis of the glenohumeral joint
Acromion to humeral head distance measuring 6mm or smaller.
Prior surgery to the involved shoulder
Dementia or inability to complete questionnaires and assessments

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Netherlands10 sites

Slootervaart ziekenhuis
Amsterdam, 1066EC
Kliniek De Lairesse
Amsterdam, 1075BG
OLVG
Amsterdam, 1090HM
Gelre ziekenhuis
Apeldoorn, 7334DZ
Amphia ziekenhuis
Breda, 4819JV
Groene Hart Ziekenhuis
Gouda, 2803HH
Tergooi Ziekenhuizen
Hilversum
Spaarne Ziekenhuis
Hoofddorp
St Antonius
Nieuwegein, 3430EM
Canisius Wilehelmina Zkh
Nijmegen

Other trials in Netherlands

About this study

Official title: Long Head Biceps Tenodesis or Tenotomy in Arthroscopic Rotator Cuff Repair: An International Multicenter Prospective Randomized Clinical Trial

During arthroscopic rotator cuff (infraspinatus/supraspinatus) repair, biceps tendon lesions are frequently encountered. However, the most optimal treatment of the diseased long head of the biceps (LHB) tendon during rotator cuff repair remains a topic of debate: tenotomy or tenodesis. The hypothesis is that there is no difference in functional outcome between LHB tenotomy and LHB tenodesis when performed in adjunct to arthroscopic rotator cuff repair.

Read the detailed description

Patients older than 50 years with a supraspinatus and/or infraspinatus tendon rupture sized smaller than 3cm, who are encountered with LHB pathology, will be randomized to either LHB tenotomy or LHB tenodesis. Clinical and self-reported data will be collected pre-operatively, and 6 weeks, 3 months, and 1 year after surgery.

Primary outcome is overall shoulder function evaluated with the Constant score. As additional measures of shoulder function, the Dutch Oxford Shoulder Test and the Disabilities of the Arm Shoulder and Hand questionnaire will be assessed. Other evaluations include cosmetic appearance evaluated by the ''Popeye'' deformity, arm cramping pain, elbow flexion strength, MRI evaluation, quality of life, and cost of surgery. To detect non-inferiority with a one-sided, two-sample t-test with a 80% power and a significance level (alpha) of 0.025, the required sample size is 98 patients.

Conditions: Rotator Cuff Syndrome
Being tested: Arthroscopic rotator cuff repair, LHB Tenodesis, LHB Tenotomy
Keywords: Popeye, Long Head Biceps Tendon, Arthroscopy, Functional result

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Arthroscopic rotator cuff repairProcedure or surgery
Arthroscopic rotator cuff repair using suture anchors
LHB TenodesisProcedure or surgery
Arthroscopic tenotomy and subsequent fixation of long head biceps proximal in the biceps groove
LHB TenotomyProcedure or surgery
Arthroscopic tenotomy of long head biceps

Study groups in NCT02655848
Study group	Role	What they receive
@ Cuff repair with LHB tenodesis	Active comparator	In case of pathologic changes of the long Head Biceps tendon, a tenodesis is performed in adjunct to performing an arthroscopic rotator cuff repair. Receives: Procedure: Arthroscopic rotator cuff repair; Procedure: LHB Tenodesis
@ cuff repair with LHB tenotomy	Active comparator	In case of pathologic changes of the long Head Biceps tendon, a tenotomy is performed in adjunct to performing an arthroscopic rotator cuff repair. Receives: Procedure: Arthroscopic rotator cuff repair; Procedure: LHB Tenotomy

What is being measured

The primary outcome is the main question the study is designed to answer.

Shoulder function quantified with the Constant score (0-100)
Sum of the items below:
ADL: Patient reported shoulder function during work (0-4), recreation/sports (0-4), and sleep (0-2).
Pain: Patient reported pain in the shoulder (severe=0,moderate=5,mild=10,no pain=15).
ROM: Anteflexion up to waist(2)/xiphoid process(4)/neck(6)/head(8)/above head(10) Elevation in degrees: 0-30(0)/31-60(2)/61-90(4)/91-120(6)/121-150(8)/151-180(10) Abduction in degrees: 0-30(0)/31-60(2)/61-90(4)/91-120(6)/121-150(8)/151-180(10) External rotation: impossible to reach head with hand(0)/hand behind head-elbow forward(2)/hand behind head-elbow backward(4)/hand on head-elbow forward(6)/hand on head-elbow backward(8)/full elevation hand from head(10) Internal rotation: dorsal part of the hand reaching lateral thigh(0)/buttock(2)/lumbo-sacral junction(4)/L3(6)/Th12(8)/between scapulae(10).
Abduction force at 90 degrees in pounds (max. 25)
Measured: 1 year

Secondary outcomes (10)

Popeye phenomenon
Presence of a Popeye deformity in the upper arm (yes/no), as reported by the patient, the treating surgeon, and a blinded assessor.
Measured: 1 year
Cosmetic appearance
Patients will assess cosmetic appearance on a VAS scale.
Measured: 1 year
MRI-based location of the biceps tendon
MRI imaging at 1 year after surgery will be used to assess the location of the proximal biceps tendon. Absence of the biceps tendon in the bicipital groove confirms a successfully performed LHB tenotomy. Absence of the biceps tendon in the bicipital groove confirms failed LHB tendodesis. In addition, the rotator cuff is classified as fully healed, partially healed or recurrent rupture.
Measured: 1 year
Self-reported shoulder function
Patients will complete two validated questionnaires: the Disabilities of Arm, Shoulder and Hand Questionnaire (DASH) and the Dutch Oxford Shoulder Test (DOST)
Measured: 1 year
Pain
Patients will be asked to report if they have pain (yes/no), and to indicate the level of pain on a VAS scale. The VAS scores will be recorded separately for general pain and for pain in the bicipital groove.
Measured: 1 year
Elbow flexion strength
A dynamometer will be used to assess elbow flexion strength with the lower arm in full supination. The Elbow Strength Index is calculated by dividing the strength in the affected side by the strength in the contralateral side.
Measured: 1 year
Quality of life
Patients will complete the validated questionnaire 'EQ-5D', which covers 5 domains (mobility, personal care, daily activities, pain and mood), as well as a 100 point thermometer on general health.
Measured: 1 year
Post-operative status of rotator cuff
Based on MRI imaging at 1 year after surgery, the rotator cuff is classified as fully healed, partially healed or recurrent rupture.
Measured: 1 year
Duration of surgery
The duration of surgery will be calculated based on the start and end times of each surgery.
Measured: 1 year
Complications
All complications and serious adverse events in the study population are recorded.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2012Sep 2019

First posted14 Jan 2016 (estimated)
Study startJul 2012
Primary completionSep 2019
Study completionSep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Rotator Cuff SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02655848
Sponsor's protocol ID: WO 10.087
Acronym: BITE
Status last verified: Sep 2019
First submitted: 29 Dec 2015
Last updated: 1 Oct 2019
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Gurnani N, van Deurzen DF, Janmaat VT, van den Bekerom MP. Tenotomy or tenodesis for pathology of the long head of the biceps brachii: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2016 Dec;24(12):3765-3771. doi: 10.1007/s00167-015-3640-6. Epub 2015 May 15.
PubMed 25975753
Zhang Q, Zhou J, Ge H, Cheng B. Tenotomy or tenodesis for long head biceps lesions in shoulders with reparable rotator cuff tears: a prospective randomised trial. Knee Surg Sports Traumatol Arthrosc. 2015 Feb;23(2):464-9. doi: 10.1007/s00167-013-2587-8. Epub 2013 Jul 5.
PubMed 23828089
Galasso O, Gasparini G, De Benedetto M, Familiari F, Castricini R. Tenotomy versus tenodesis in the treatment of the long head of biceps brachii tendon lesions. BMC Musculoskelet Disord. 2012 Oct 22;13:205. doi: 10.1186/1471-2474-13-205.
PubMed 23088416
van Deurzen DF, Scholtes VA, Willigenburg NW, Gurnani N, Verweij LP, van den Bekerom MP; BITE collaboration group. Long head BIceps TEnodesis or tenotomy in arthroscopic rotator cuff repair: BITE study protocol. BMC Musculoskelet Disord. 2016 Aug 30;17(1):375. doi: 10.1186/s12891-016-1230-5.
PubMed 27577549

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
The Effectiveness of High-intensity Laser Therapy in Femoroacetabular Impingement Syndrome
Femoroacetabular Impingement Syndrome, Femoro-acetabular Impingement
Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Recruiting
Device-Assisted Balance Training for People With Shoulder Impingement
Shoulder
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Active, not recruiting
Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications?
Femoroacetabular Impingement Syndrome

All Rotator Cuff Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long Head Biceps Tenodesis or Tenotomy in Arthroscopic Rotator Cuff Repair: An International Multicenter Prospective Randomized Clinical Trial
ClinicalTrials.gov ID: NCT02655848
Acronym / sponsor ID: BITE / WO 10.087
Conditions: Rotator Cuff Syndrome
Keywords: Popeye, Long Head Biceps Tendon, Arthroscopy, Functional result
Study type: Interventional
Recruitment status: Completed
Enrolment: 98 participants (actual)
Lead sponsor: Onze Lieve Vrouwe GasthuisUniversity, hospital or other
Collaborators: Nederlandse Vereniging voor Arthroscopie, Smith & Nephew, Inc.
Study start: Jul 2012
Primary completion: Sep 2019 (actual)
Study completion: Sep 2019 (actual)
First posted: 14 Jan 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
@ Cuff repair with LHB tenodesis	Active comparator	Procedure: Arthroscopic rotator cuff repair, Procedure: LHB TenodesisIn case of pathologic changes of the long Head Biceps tendon, a tenodesis is performed in adjunct to performing an arthroscopic rotator cuff repair.
@ cuff repair with LHB tenotomy	Active comparator	Procedure: Arthroscopic rotator cuff repair, Procedure: LHB TenotomyIn case of pathologic changes of the long Head Biceps tendon, a tenotomy is performed in adjunct to performing an arthroscopic rotator cuff repair.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients older than 50 years
Degenerative rotator cuff lesion of supraspinatus/infraspinatus tendon, smaller than three centimeter.
Patients need to be able to read and write in Dutch or English language in order to complete the questionnaires, and sign informed consent.

Key exclusion criteria (7 listed)

Acute, traumatic or partial thickness rotator cuff rupture, or in case a full thickness tear is larger than 3 cm measured using an arthroscopic ruler.
Accompanying subscapularis tendon lesion
Hour-glass deformation bicepstendon origin or in case of accompanying subscapularis tendon rupture.
Osteoarthritis of the glenohumeral joint
Acromion to humeral head distance measuring 6mm or smaller.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Arthroscopic rotator cuff repairArthroscopic rotator cuff repair using suture anchors	Procedure or surgery	@ Cuff repair with LHB tenodesis, @ cuff repair with LHB tenotomy
LHB TenodesisArthroscopic tenotomy and subsequent fixation of long head biceps proximal in the biceps groove	Procedure or surgery	@ Cuff repair with LHB tenodesis
LHB TenotomyArthroscopic tenotomy of long head biceps	Procedure or surgery	@ cuff repair with LHB tenotomy

Primary outcome

Shoulder function quantified with the Constant score (0-100)
Time frame: 1 year
Sum of the items below: ADL: Patient reported shoulder function during work (0-4), recreation/sports (0-4), and sleep (0-2). Pain: Patient reported pain in the shoulder (severe=0,moderate=5,mild=10,no pain=15). ROM: Anteflexion up to waist(2)/xiphoid process(4)/neck(6)/head(8)/above head(10) Elevation in degrees: 0-30(0)/31-60(2)/61-90(4)/91-120(6)/121-150(8)/151-180(10) Abduction in degrees: 0-30(0)/31-60(2)/61-90(4)/91-120(6)/121-150(8)/151-180(10) External rotation: impossible to reach head with hand(0)/hand behind head-elbow forward(2)/hand behind head-elbow backward(4)/hand on head-elbow forward(6)/hand on head-elbow backward(8)/full elevation hand from head(10) Internal rotation: dorsal part of the hand reaching lateral thigh(0)/buttock(2)/lumbo-sacral junction(4)/L3(6)/Th12(8)/between scapulae(10). Abduction force at 90 degrees in pounds (max. 25)

10 secondary outcomes

Popeye phenomenon
Time frame: 1 year
Cosmetic appearance
Time frame: 1 year
MRI-based location of the biceps tendon
Time frame: 1 year
Self-reported shoulder function
Time frame: 1 year
Pain
Time frame: 1 year
Elbow flexion strength
Time frame: 1 year
Quality of life
Time frame: 1 year
Post-operative status of rotator cuff
Time frame: 1 year
Duration of surgery
Time frame: 1 year
Complications
Time frame: 1 year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
Background: PubMed 25975753Gurnani N, van Deurzen DF, Janmaat VT, van den Bekerom MP. Tenotomy or tenodesis for pathology of the long head of the biceps brachii: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2016 Dec;24(12):3765-3771. doi: 10.1007/s00167-015-3640-6. Epub 2015 May 15.
Background: PubMed 23828089Zhang Q, Zhou J, Ge H, Cheng B. Tenotomy or tenodesis for long head biceps lesions in shoulders with reparable rotator cuff tears: a prospective randomised trial. Knee Surg Sports Traumatol Arthrosc. 2015 Feb;23(2):464-9. doi: 10.1007/s00167-013-2587-8. Epub 2013 Jul 5.
Background: PubMed 23088416Galasso O, Gasparini G, De Benedetto M, Familiari F, Castricini R. Tenotomy versus tenodesis in the treatment of the long head of biceps brachii tendon lesions. BMC Musculoskelet Disord. 2012 Oct 22;13:205. doi: 10.1186/1471-2474-13-205.
Derived from this study: PubMed 27577549van Deurzen DF, Scholtes VA, Willigenburg NW, Gurnani N, Verweij LP, van den Bekerom MP; BITE collaboration group. Long head BIceps TEnodesis or tenotomy in arthroscopic rotator cuff repair: BITE study protocol. BMC Musculoskelet Disord. 2016 Aug 30;17(1):375. doi: 10.1186/s12891-016-1230-5.
Individual participant dataSharing planned: No

Related trials for Rotator Cuff Syndrome

Not yet recruiting
The Effectiveness of High-intensity Laser Therapy in Femoroacetabular Impingement Syndrome
Femoroacetabular Impingement Syndrome, Femoro-acetabular Impingement
Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Recruiting
Device-Assisted Balance Training for People With Shoulder Impingement
Shoulder
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Active, not recruiting
Can Perineal Post-Free Traction in Hip Arthroscopy Effectively Reduce Perineal Complications?
Femoroacetabular Impingement Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Derek van Deurzen, MD principal investigator

OLVG

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Arthroscopic rotator cuff repair, LHB Tenodesis and LHB Tenotomy in people with Rotator Cuff Syndrome, run by Onze Lieve Vrouwe Gasthuis at 10 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Shoulder function quantified with the Constant score (0-100) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02655848, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.